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Myringotomy Knife

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref NZ3245-10

by Adept Medical Ltd

Identity

Trade Name
Myringotomy Knife EUDAMED
Adept Medical Myringotomy Knife FDA UDI
Generic Name
Tympanotomy knife, single-use FDA UDI
Device Name
Myringotomy Knife EUDAMED
Model / Reference
NZ3245-10 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
09421901970499 EUDAMEDFDA UDI
Basic UDI-DI
9421905187MyrinKniZW EUDAMED
FDA Product Code
JYP FDA UDI
EMDN Code
Q030301 ENT SURGERY BLADES, SINGLE-USE EUDAMED
GMDN Term
Tympanotomy knife, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
874.4420 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Myringotomy Knife by Adept Medical Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Adept Medical Ltd
EUDAMED SRN
NZ-MF-000003374
Authorised Representative
Qualrep Services B.V. NL-AR-000000537

Sources (2)

  • EUDAMED a67ddf25-5cef-472e-97a4-e1637bd0f716 61 fields · synced Jun 17, 2026
  • FDA UDI d237d9dd-3d0f-49a2-9c84-5d2500076dab 32 fields · synced May 30, 2026